On Your Marks: The Humira Biosimilar Race begins, but not in the U.S.

12 Oct 18

12 Oct 2018 On Your Marks: The Humira Biosimilar Race begins, but not in the U.S.

Introduction

Five biosimilar copies of the world’s highest selling drug, Humira (adalimumab), are about to launch simultaneously in Europe. In the US, however, no launches are expected before 2023. In this edition we explore this unprecedented event and how Europe continues to outpace the US in biosimilar launches.

The European starting gun is set to fire

October 16th 2018 marks the start date for up to five biosimilar competitors all poised to launch their respective copies of Abbvie’s Humira (adalimumab) across Europe.

Amgen, Samsung Bioepis, Boehringer Ingelheim, Sandoz and Mylan have all received European approval for their biosimilar products referencing AbbVie’s mega-blockbuster. Not only will these five be vying against branded Humira, but also competing for market share amongst themselves and any other subsequent biosimilar entrants.

This event is the first of its kind and contrasts previous launches in Europe where biosimilars of the same reference product have entered the market sequentially. As it stands, all five companies appear ready to launch their biosimilars as of October 16th.

Europe is ready for biosimilar uptake

National agencies have been preparing for this occasion for several months. In March, England’s National Health Service (NHS) issued an update across the country designed to encourage adalimumab biosimilar uptake once the products become available later this month. The NHS anticipates adalimumab biosimilars will reduce the £333 million they spend on Humira each year and help achieve their 2020/2021 goal of £200 million to £300 million in annual savings through biosimilars.

Additionally, with five years of anti-TNF biosimilar experience gained through infliximab and etanercept biosimilars, the broader European market is well prepared for the onset of multiple adalimumab biosimilars.

But uniform biosimilar uptake is not expected

As we’ve learnt from past biosimilar experience, uptake across Europe is likely to vary significantly due to differences in national procurement policies. In Nordic countries such as Denmark and Norway, existing biosimilars have come to occupy over 90% of the market through single-winner national tendering systems. In contrast, countries such as Italy have experienced far less biosimilar adoption due to their comparatively conservative approach.

Nevertheless, anticipation is building as biosimilar competition threatens over $4.4 billion in European Humira sales.

The US / Europe disparity

This landmark event in Europe contrasts to the situation in the US.

Humira currently generates over $12 billion in sales per year in the US alone (compared to $4.4 billion in Europe). That’s $34 million per day for AbbVie. It’s no surprise, then, that AbbVie has been exhaustive and largely successful in extending its monopoly in the US.

While five distinct adalimumab biosimilars are set to launch in Europe, the earliest US launch date settled upon by these competitors is not until January 2023 by Amgen. Four of the five biosimilar players have now settled legal disputes with AbbVie and agreed to hold off entering US until 2023. Boehringer Ingelheim is the last competitor yet to settle as it continues challenging AbbVie in legal battles.

Why the US lag?

Intellectual property barriers, referred to as the Humira patent ‘thicket’, have proven the largest barrier for biosimilar entry into the US.

According to a recent case study from the Initiative for Medicines, Access, and Knowledge (I-MAK), 247 patents have been filed in the US with the aim to restrict Humira competition for 39 years. The report also states that nearly half of the 247 patents filed by AbbVie in the US were filed after 2014, and a staggering 89% of patents were filed after Humira launched in 2003.

But the situation is different in Europe. AbbVie has filed over three times as many patent applications in the US compared to Europe. I-MAK authors state that patents filed after 2002 in the US designed to extend Humira’s monopoly “were either withdrawn, refused during examination, or revoked after patent challenges” in Europe.

Summary

NeuClone looks on with anticipation as Europe prepares for the launch of up to five Humira biosimilars simultaneously. However, elsewhere our enthusiasm is dampened, unfortunately, by the intellectual property climate in the US that will restrict thousands of patients accessing critical therapeutics and place huge financial burdens on an already strained healthcare system.